check_circleStudy Completed

Contraception

Bayer Identifier:

14701

ClinicalTrials.gov Identifier:

NCT01257984

EudraCT Number:

2010-019902-17

EU CT Number:

Not Available
Study to investigate compliance with the oral contraceptive SH T00186D in a flexible extended regimen supported by a dispenser with a reminder function

Trial purpose

The objective of the study is to evaluate the effect of the dispenser’s buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection
  • - Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
    - Body mass index (BMI) >/= 30.0 kg/m2
    - Presence or a history of venous or arterial thrombotic/thromboembolic events
    - Repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
    - Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous COC use
    - Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
    - Severe dyslipoproteinemia
    - Malignant or premalignant disease
    - Uncontrolled thyroid disorder
    - Chronic inflammatory bowel disease
    - Severe renal insufficiency or acute renal failure
    - History of migraine with focal neurologic symptoms
    - Epilepsy

Trial summary

Enrollment Goal
508
Trial Dates
December 2010 - September 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60590, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69115, Germany
Completed
Praxis Dr. A. Schwenkhagen-StodieckHamburg, 20357, Germany
Completed
Praxis Dr. S. Mucha & Dr. G. SchalkWuppertal, 42103, Germany
Completed
Frauenarztpraxis Dipl. med. Michael StellmacherBurg, 39288, Germany
Completed
Frauenarztpraxis Dr. med. Gabriele WeinreichMagdeburg, 39130, Germany
Completed
Frauenarztpraxis Dr. WetzelBlankenburg, 38889, Germany
Completed
Praxis Hr. Dr. R. EtzrodtGera, 07545, Germany
Completed
Praxis Fr. Dr. A.Mönch-HeringKahla, 07768, Germany
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
A.O.U. di CagliariCagliari, 09124, Italy
Completed
A.O.U. di Bologna - Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
A.O.U. di Modena PoliclinicoModena, 41124, Italy
Completed
A.O.U. Policlinico - Vittorio EmanueleCatania, 95123, Italy
Completed
A.O.U. Policlinico GiacconePalermo, 90127, Italy
Terminated
A.O.U. Seconda UniversitàNapoli, 80138, Italy
Completed
IRCCS Fondazione Maugeri Clinica Lavoro e RiabilitazionePavia, 27100, Italy
Completed
A.O. Spedali CiviliBrescia, 25123, Italy
Completed
Centro de Atención Primaria Ramón Turró-PASSIRBarcelona, 08019, Spain
Completed
Centro de Salud Sexual y Reproductiva ELDAElda, 03600, Spain
Completed
Centro de Orientación Sexual para Jóvenes. CS La VictoriaMálaga, 29013, Spain
Completed
H.Universitario Madrid MontepríncipeBoadilla del Monte, 28660, Spain
Completed
Hospital Reina SofíaCórdoba, 14004, Spain
Completed
The Health CentreBradford-on-Avon, BA15 1DQ, United Kingdom
Completed
St James's SurgeryBath, BA1 2SR, United Kingdom
Completed
The Porch SurgeryCorsham, SN3 9DL, United Kingdom
Completed
Ely Bridge Medical CentreCardiff, CF5 4AD, United Kingdom
Completed
The Medical CentreEast Horsley, KT24 6QT, United Kingdom
Completed
Greenwood and Sneinton Family Medical CentreNottingham, NG2 4PJ, United Kingdom
Completed
Avondale SurgeryChesterfield, S40 4TF, United Kingdom
Completed
A.O. Sant'AndreaRoma, 00189, Italy
Completed
Cabinet Médical - Loiret - OlivetOLIVET, 45160, France
Completed
Cabinet Médical - Villersexel - ParisPARIS, 75007, France
Completed
Dr. Aliette Siboni-FrischToulouse, 31000, France
Completed
Cabinet gynecologieBIARRITZ, 64200, France
Completed
Dr Cecile PetrequinParis, 75018, France
Completed
CM Ehret-MentreSTRASBOURG, 67 000, France
Completed
CM LabouzSTRASBOURG, 67 000, France
Completed
CM SchefflerNANCY, 54000, France
Terminated
CM DagoussetPARIS, 75 017, France
Completed
CM Missey KolbMARLY LE ROI, 78160, France
Completed
A.O. Istituti Clinici di PerfezionamentoMilano, 20154, Italy
Completed
CM LecocqPARIS, 75 009, France

Primary Outcome

  • Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of delayed and missed pills
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding pattern and cycle control parameters
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Length of the tablet break and the length of the bleeding episode preceding the tablet break
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

A multicenter, open-label, randomized, controlled, two-arm study to assess compliance with daily tablet intake of women on treatment with the oral contraceptive SH T00186D/BAY 86-5300 (0.02 mg ethinyl estradiol as betadex clathrate and 3 mg drospirenone) in a flexible extended regimen supported by a dispenser with a reminder function over 12 months
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
2

Additional Information

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